# K230203: Dentis I-FIX Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: May 3, 2023 after 98 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931767 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210826: Healing Abutment, Cover Screw, Megagen Implant Co., Ltd. (2022) Summary page 4.

## Indications for use
Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K230203
Methodology: https://510kreport.com/methodology